HPV-related Oropharyngeal and Uncommon Cancers Screening (HOUSTON)
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| ClinicalTrials.gov Identifier: NCT02897427 |
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Recruitment Status :
Recruiting
First Posted : September 13, 2016
Last Update Posted : December 20, 2018
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Sponsor:
M.D. Anderson Cancer Center
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
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Brief Summary:
This trial studies the screening of human papillomavirus (HPV)-related oropharyngeal and uncommon cancers. Learning the relationship between HPV and cancer risk in men who test positive for HPV antibodies may help doctors to develop early methods of screening for certain types of cancer, and screening for HPV may help doctors to learn which patients may be at a higher risk for developing certain types of cancer.
| Condition or disease | Intervention/treatment |
|---|---|
| Health Status Unknown | Other: Biomarker Analysis Procedure: Biospecimen Collection Procedure: Ultrasonography |
Show Detailed Description
| Study Type : | Observational |
| Estimated Enrollment : | 5000 participants |
| Observational Model: | Cohort |
| Time Perspective: | Prospective |
| Official Title: | HPV-Related Oropharyngeal and Uncommon Cancers Screening Trial of meN (HOUSTON Study) |
| Actual Study Start Date : | March 28, 2017 |
| Estimated Primary Completion Date : | March 28, 2027 |
| Estimated Study Completion Date : | March 28, 2027 |
| Group/Cohort | Intervention/treatment |
|---|---|
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Screening (specimen collection, HPV testing)
STAGE I: Participants undergo collection of blood and oral gargle samples. STAGE II: Participants complete a head and neck exam by using brushing of the oropharyngeal mucosa, a thorough oropharyngeal exam including narrow band imaging, undergo collection of oral gargle sample, transcervical ultrasonography of the neck lymph nodes and oropharynx, anoscopy, and complete Papanicolaou/HPV testing. Participants undergo repeat oropharyngeal screening, oral HPV DNA test, oral HPV integration testing, and ultrasound once every 6 months for 5 years. Participants also undergo collection of blood. |
Other: Biomarker Analysis
Complete HPV testing Procedure: Biospecimen Collection Undergo collection of blood and oral gargle samples Procedure: Ultrasonography Undergo transcervical ultrasonography
Other Names:
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Primary Outcome Measures :
- Cancer detection rate of the seropositive group [ Time Frame: Up to 5 years ]Will use the proportion equality test to compare the cancer detection rate of the seropositive group using the screening strategy with the historical rate of 0.08 (4/50). To evaluate the performance of the new techniques for early detection, will test whether the proportion of patients diagnosed at stage I, II, or III from the screening strategy is larger than the historical rate of 17.7% using the proportion equality test. Will further compute and compare the pre-cancer detection rates with the historical information.
- Prevalence of serum antibodies to human papillomavirus (HPV)16 E antigens [ Time Frame: Up to 5 years ]Will calculate the prevalence of serum antibodies to HPV16 E antigens along with 95% confidence intervals. Will use descriptive statistics to summarize the demographic and sexual behavior characteristics of study participants overall and by HPV16 E antibody status (positive, negative). Logistic regression models will be used to determine the association between serostatus or oral HPV infection status and demographic, socioeconomic, and behavioral factors.
Biospecimen Retention: Samples With DNA
blood sample for serologic testing and oral gargle sample for oral HPV testing
Information from the National Library of Medicine
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| Ages Eligible for Study: | 50 Years to 64 Years (Adult) |
| Sexes Eligible for Study: | Male |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
Study Population
MDACC Clinics
Criteria
Inclusion Criteria:
- Stage 1 Inclusion Criteria: United States (US) resident
- Stage 1 Inclusion Criteria: Fluent in English
- Stage 1 Inclusion Criteria: Sign an approved informed consent document
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Stage 2 (longitudinal study) Inclusion Criteria:
- Eligible for and enrolled in Stage 1
- Test positive to HPV16 E antibodies; be identified as a negative control; test positive for oral HPV16 infection by oral rinse; or test positive for cvDNA
- Sign an approved informed consent document
Exclusion Criteria:
- Stage 1 Exclusion Criteria: Patients with previously documented squamous cell carcinoma of the oropharynx, anus, or penis
- Stage 1 Exclusion Criteria: Received radiation cancer therapy to the head and neck in the past
- Stage 1 Exclusion Criteria: On active cancer therapy now or in the past 6 months
- Stage 1 Exclusion Criteria: Ever had a transplant (stem cell, bone marrow, or solid organ)
- Stage 1 Exclusion Criteria: Patients who received blood transfusions in the last 6 months
- Stage 1 Exclusion Criteria: Other medical or psychiatric illness or social situation that would limit study compliance
- Stage 2 (longitudinal study) Exclusion Criteria: Any seronegative and cvDNA-negative man who tests negative for oral HPV16 DNA by swab at two consecutive follow-up visits will be excluded from further follow-up. Any man who is seropositive, cvDNA-positive, or has evidence of integration at any time will continue to be followed regardless of oral HPV16 status
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02897427
Contacts
| Contact: Erich M. Sturgis | 713-792-6920 | esturgis@mdanderson.org |
Locations
| United States, Texas | |
| M D Anderson Cancer Center | Recruiting |
| Houston, Texas, United States, 77030 | |
| Contact: Erich M. Sturgis 713-792-6920 | |
| Principal Investigator: Erich M. Sturgis | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Investigators
| Principal Investigator: | Erich Sturgis | M.D. Anderson Cancer Center |
Additional Information:
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT02897427 History of Changes |
| Other Study ID Numbers: |
2016-0109 NCI-2018-02604 ( Registry Identifier: CTRP (Clinical Trial Reporting Program) ) 2016-0109 ( Other Identifier: M D Anderson Cancer Center ) P30CA016672 ( U.S. NIH Grant/Contract ) |
| First Posted: | September 13, 2016 Key Record Dates |
| Last Update Posted: | December 20, 2018 |
| Last Verified: | December 2018 |
| Studies a U.S. FDA-regulated Drug Product: | No |
| Studies a U.S. FDA-regulated Device Product: | No |